FDA 510(k) Application Details - K981360

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K981360
Device Name	Vinyl Patient Examination Glove
Applicant	GLORMED INTL., INC. 198 AVENUE DE LA D'EMERALD SPARKS, NV 89434 US Other 510(k) Applications for this Company
Contact	JANNA TUCKER Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/14/1998
Decision Date	10/15/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review